Health Measures Conference 2017

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Lizbeth Hill
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1 Characterizing Patients with Patient Acceptable Symptom State (PASS) after Selected Foot and Ankle Orthopedic Procedures using Patient Reported Outcomes Jeff Houck, PT, PhD, George Fox University Micheal Anderson, MD, University of Rochester A.Samuel Flemister, MD, University of Rochester Irvine Oh, MD, University of Rochester Benjamin DiGiovanni, MD, University of Rochester John Ketz, MD, University of Rochester Judy Baumhauer, MD University of Rochester

2 Background Patient Outcomes Patient Acceptable Symptom State (PASS) Well versus healed? Pubmed (77 studies) Cataracts, Arthritis (RA, OA, AS), generic musculoskeletal problems, and others PASS versus MCID Success/Failure Patients definition of success dependent on expectations related however distinct

3 Generic PRO s (PROMIS Scales & Global Rating of Normal Function) PROMIS T-score is abstract MCID versus PASS Benchmarks that are useful Global Rating of Normal Function (GRNF) Used widely in psychology Common question on legacy instruments (e.g. FAAM)

4 Purpose/Objectives Determine 1. association of patient outcomes PASS and Success 2. ability of generic PRO s (PROMIS and GRNF) to discriminate between positive and negative patient outcomes (aggregate) 3. ability of generic PRO s to predict positive and negative patient outcomes using preoperative assessment (PROMIS only) and at follow up 4. proportion patients identified by accurate thresholds for positive/negative outcomes.

5 Sample 90 Patients reached by phone ( months post surgery) 4/10 most common F&A surgeries Pre-operative PROMIS data available for 64 patients PARAMETERS NUMBER MEAN SD RANGE AGE GENDER FEMALE MALE 49/90 (54.4%) 41/90 (45.6%) FOLLOW-UP (MONTHS) PROCEDURE CPT subtalar arthrodesis CPT bunion correction CPT reconstruction ankle ligaments CPT deep tendon transfer OUTCOMES PASS (YES %) SUCCESSFUL GRNF PROMIS PF PROMIS PI PROMIS D 17/90 (18.9%) 15/90 (16.7%) 29/90 (32.2%) 29/90 (32.2%) 66/90 (73.3%) 75/90 (83.0%)

6 Patient Outcomes Concept Success/Failure Patient Acceptable Symptom State (PASS) Dichotomous Question Which of the following applies to you? I consider my surgery a success I consider my surgery a failure Taking into account all the activity you have during your daily life, your level of pain, and also your functional impairment, do you consider that the current state of your foot and ankle is satisfactory? Yes N0

7 Generic Patient Reported Outcomes (PRO s) PRO Global Rating of Normal Function (GRNF) Patient Reported Outcome Instrumentation System (PROMIS) Rating/Instrument How would you rate the function of your foot and ankle on a scale of 0-10 with 10 being normal, excellent function and 0 being the inability to perform any of your usual daily activities which may include sports? Pain Interference CAT Physical Function CAT Depression CAT

8 Analyses Determine 1. association of patient outcomes PASS and Success Chi-square analysis (2x2 table) 2. ability of generic PRO s (PROMIS and GRNF) to discriminate between positive and negative patient outcomes (aggregate) Two Way ANOVA (PROMIS Scales) & Mann-Whitney U test (GRNF) 3. ability of generic PRO s to predict positive and negative patient outcomes using preoperative assessment (PROMIS only) and at follow up ROC analysis, thresholds nearest 95 % sensitivity/specificity 4. proportion of patients identified by accurate thresholds for positive/negative outcomes for each generic measure. Chi-square analysis 3x2 tables (predicted Positive outcome, negative outcome, and ambiguous)

9 1. association of patient outcomes PASS and Success PASS Success Failure Total Chi Square, p value No 11 (12.2%) 13 (14.4%) 26.7% Yes 64 (71.1%) 2 (2.2 %) 73.3% 33.1, p < 0.001

10 2....discriminate between positive/negative patient outcomes Average Follow Up Average PROMIS Scores for PASS Yes/No Average Follow Up Average PROMIS Scores for Success Yes/No t-score 30 PASS NO PASS YES t-score 30 Success NO Success YES PROMIS PF PROMIS PI PROMIS Depression 0 PROMIS PF PROMIS PI PROMIS Depression PROMIS Scales PROMIS Scales

11 3. to predict positive/negative patient outcomes Reciever Operator Curves of Pre-Operative and Follow Up PROMIS Scores Predicting PASS 1 PF Follow Up 0.9 PI Follow Up 0.8 Depression Follow Up PF Pre-Operative 0.7 PI Pre-Operative 0.6 Depression Pre-Operative Sensitivity Reciever Operator Curves for Pre-Operative and Follow Up PROMIS Scores Predicting "Success" Sensitivity PF Follow Up PI Follow Up Depression Follow Up PF Pre-Operative PI Pre-Operative Depression Pre-Operative Specificity Specificity

Thresholds for Positive/Negative Patient Outcomes PARAMETER PASS YES PASS NO SENSITIVITY SPECIFICITY PARAMETER SUCCESS FAILURE SENSITIVITY SPECIFICITY GRNF >7 <5 97.1 % 93.8 % PF >50.0 <33.5 95.7% 95.

12 Thresholds for Positive/Negative Patient Outcomes PARAMETER PASS YES PASS NO SENSITIVITY SPECIFICITY PARAMETER SUCCESS FAILURE SENSITIVITY SPECIFICITY GRNF >7 < % 93.8 % PF >50.0 < % 95.8 % PI <46.9 > % 95.8 % DEPRESSION <44.0 > % 91.3 % GRNF >6* < % 73.3 %* PF >45.3 < % 92.3 % PI <47.3 > % 92.3 % DEPRESSION <45.8 > % 85.7 % *note using >7 as the cut off yields a specificity of 100%

13 4. proportion of patients identified PROMIS PI SUCCESS FAILURE TOTAL CHI SQUARE, P VALUE GRNF SUCCESS FAILURE TOTAL CHI SQUARE, P VALUE >64.5 FAILURE 4 (4.4%) 6 (6.7 %) 11.1% <5 FAILURE 4 (4.4%) 8 (8.9%) 13.3% AMBIGUOUS 39 (43.3%) 8 (8.9%) 52.2% 17.9, p< AMBIGUOUS 14 (15.6%) 3 (3.3%) 18.9% 26.1, p < <47.3 SUCCESS 32 (35.6%) 1 (1.1%) 36.7% >7 SUCCESS 57 (63.3%) 4 (4.4%) 67.8% All proportions (categorizations) based on generic PRO s were significant % of patients were accurately identified (95% Sn/Sp) Positive outcomes (PASS yes or Success) were more successfully predicted than negative outcomes

14 Summary The PASS and Success definitions of patient outcome are similar but not the same Generic PRO s assessed discriminate groups based on patient outcome PROMIS and GRNF were predictive of current patient status (Follow Up), however, pre-operative scores did NOT predict Follow Up data. High proportions (43-81%) were identified by ONLY taking into account PRO assessments.

15 Notable Limitations Sample was too small to derive and validate thresholds Number of surgical failures was small so models are likely overfit Specific diagnoses may give different results Representative sample (contacted versus not-contacted patients same mean age and % female)?

16 Questions Health Measures

Abstracts Listed Numerically

Abstracts Listed Numerically 1. Clinical Utilization of Patient Reported Outcome (PROMIS) Scores for Surgical Reconstruction of Posterior Tibialis Tendon Dysfunction Michel R. Anderson, MD 1, Judith F.